FDA UDI
In Commercial Distribution
🇺🇸 United States
Power-LOAD
DI: 07613327504453
·
Model: 639005550003
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Power-LOAD
- Primary DI
- 07613327504453
- Version / Model
- 639005550003
- Catalog Number
- 639005550003
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 078470558
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-17
- Public Version
- 1
- Public Version Date
- 2019-12-25
- Public Version Status
- New
- Public Device Record Key
- 257ec58d-2e61-4894-9307-2c7bed8d7ac0
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPO | STRETCHER, WHEELED | General Hospital | 880.6910 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60422 | Gel-filled bed mattress | A large, durable, fabric case filled with various densities of foam that support a gel structure, designed to be placed on a bed mattress support platform to provide a comfortable surface on which an occupant can lie, rest, and sleep, and intended to distribute body weight over a large surface area typically to help relieve pressure points for comfort and improve blood circulation to prevent pressure sores. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327504453 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K113598 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 158 Degrees Fahrenheit
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 93 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- -30 – 130 Degrees Fahrenheit